NGENLA Dosage & Rx Info | Uses, Side Effects

Ngenla Generic Name & Formulations

Legal Class

General Description

Somatrogon-ghla 24mg/1.2mL, 60mg/1.2mL; soln for SC inj.

Pharmacological Class

Growth hormone (GH).

How Supplied

Single-patient-use prefilled pen—1

Storage

Before first use: Store refrigerated at 36°F to 46°F (2°C to 8°C) in the original carton to protect from light.

After first use: Store the pen refrigerated at 36°F to 46°F (2°C to 8°C) between each use, for up to 28 days.

Do not freeze or shake. Do not expose to heat. Do not use if it has been frozen. Store away from direct sunlight.

Manufacturer

Pfizer Inc.

Generic Availability

Mechanism of Action

Somatrogon-ghla binds to the GH receptor and initiates a signal transduction cascade culminating in changes in growth and metabolism. Somatrogon-ghla binding leads to activation of the STAT5b signaling pathway and increases the serum concentration of Insulin-like Growth Factor (IGF-1). GH and IGF-1 stimulate metabolic changes, linear growth, and enhance growth velocity in pediatric patients with GHD.

Ngenla Indications

Indications

Growth failure in children ≥3yrs due to inadequate secretion of endogenous growth hormone (GH).

Ngenla Dosage and Administration

Adult

Not applicable.

Children

<3yrs: not established. Give by SC inj into abdomen, thighs, buttocks, or upper arms at same day each week; rotate inj site weekly. Day of weekly administration can be changed if ≥3 days between 2 doses. Give each inj at different site if multiple inj required for a complete dose. Individualize. ≥3yrs: 0.66mg/kg once weekly. Switching from daily growth hormone: initiate Ngenla on the day after last daily inj.

Ngenla Contraindications

Contraindications

Acute critical illness after open heart surgery, abdominal surgery or multiple accidental trauma or those with acute respiratory failure. Closed epiphyses. Active malignancy. Active proliferative or severe non-proliferative diabetic retinopathy. History of upper airway obstruction or sleep apnea, severe obesity, or severe respiratory impairment in children with Prader-Willi syndrome (PWS).

Ngenla Boxed Warnings

Not Applicable

Ngenla Warnings/Precautions

Warnings/Precautions

Increased mortality in those with acute critical illness (see Contraindications). Not for treatment of children with growth failure due to PWS. Increased risk of malignancies; if preexisting, complete treatment prior to Ngenla initiation; discontinue if there is evidence of recurrent activity. History of GHD secondary to intracranial neoplasm: monitor for tumor progression or recurrence. Monitor for increased growth or malignant changes of preexisting nevi. Risk for diabetes mellitus (eg, obesity, Turner syndrome, family history); monitor glucose levels periodically. Preexisting diabetes; monitor closely. Intracranial hypertension: perform routine fundoscopic exam at baseline and periodically thereafter; evaluate and treat if papilledema identified. Temporarily discontinue if evidence of intracranial hypertension occurs; may restart therapy at a lower dose if resolved. Hypoadrenalism: monitor for reduced serum cortisol levels. Hypothyroidism. Monitor thyroid function. Scoliosis (monitor). May increase serum phosphorous, alkaline phosphatase, parathyroid hormone after therapy. Pregnancy. Nursing mothers.

Ngenla Pharmacokinetics

Distribution

Apparent volume of distribution: 0.342 L/kg (central); 0.671 L/kg (peripheral).

Metabolism

Protein catabolism.

Elimination

Half-life: 37.7 hours.

Ngenla Interactions

Interactions

May require an increase in maintenance or stress doses of glucocorticoid replacement in hypoadrenalism (eg, cortisone acetate, prednisone). May be antagonized by replacement glucocorticoids; adjust glucocorticoid dose. Concomitant drugs metabolized by CYP450 enzymes; monitor carefully. Antidiabetic medications may need to be adjusted. Women on oral estrogen: may need higher Ngenla dose. May interfere with hCG blood or urine pregnancy testing; use alternative methods.

Ngenla Adverse Reactions

Adverse Reactions

Inj site reactions, nasopharyngitis, headache, pyrexia, anemia, cough, vomiting, hypothyroidism, abdominal pain, rash, oropharyngeal pain; severe hypersensitivity, neoplasms, intracranial hypertension, fluid retention, hypoadrenalism, hypothyroidism, slipped capital femoral epiphysis, pancreatitis, lipoatrophy.

Ngenla Clinical Trials

Clinical Trials

The approval was based on data from a multicenter, randomized, open-label, active-controlled, parallel-group phase 3 study (ClinicalTrials.gov Identifier: NCT02968004), which assessed the efficacy and safety of once-weekly somatrogon to daily injections with somatropin (Genotropin) in 224 treatment-naïve prepubertal pediatric patients with growth hormone deficiency. The primary endpoint was the annualized height velocity at week 52.

Results showed that treatment with somatrogon was noninferior to somatropin, as measured by annual height velocity at week 52 (10.1cm/year vs 9.8cm/year, respectively; mean least squares treatment difference, 0.3 [95% CI, -0.2, 0.9]). The mean height standard deviation score (SDS) at week 52 was -1.94 in the somatrogon arm and -1.99 in the somatropin arm. The mean increase in height SDS from baseline at week 52 was 0.92 in the somatrogon arm and 0.87 in the somatropin arm.

Ngenla Note